Table 3.

Stakeholder engagement during the implementation phase for STREAM clinical trial

Stakeholders	Engagement activities/approach	Communication activities	Barriers addressed by activities	Impact of engagement
MoH ( Centre for Health Development )	Activities: Regular meetings with regulator (approximately once a month) to submit information and obtain import/export licenses, minimizing delays in trial operations Strategic insights: Proactive licensing coordination with the regulator was essential to ensure a stable supply of trial-related medications (preventing disruptions in patient treatment and study timelines) and timely export of samples for analysis	Timing: Continuing throughout implementation after Site initiation Mode: In-person Frequency: As needed (Approx. monthly) to ensure timely import of trial drugs, equipment and export of samples Written materials used (if any): N/A	Ethical and regulatory system obstacles Lack of favorable research environment Operational barriers	Improved understanding and faster response by regulators to trial requirements, resulting in more efficient import of trial supplies and export of specimens Trial avoided regulatory delays by providing complete/timely information to government agencies
SC and EC	Activities: Site met with SC and EC to explain major protocol amendments and significant PDs/SAEs Site provided SC and EC with information in the format requested—including translations, summary, table of amendments, rationale etc. Site and EC agreed on the form and format of reporting protocol deviations, Serious adverse events etc. Strategic insights: Providing committees with comprehensive overviews of major protocol amendments, SAEs, and other significant issues ensured committee members remained up to date and reduced delays.	Timing: In advance of major protocol amendments and other major events Mode: In-person/Follow on emails to ensure timely decision-making Frequency: Approx. eight in-person meetings Written materials used (if any): Typically, a summary table of changes to the protocol was necessary for protocol amendments. Sometimes PowerPoint presentations were prepared. Other information provided in the format requested by the committees	Lack of favorable research environment Operational barriers	Site, SC and EC managed protocol amendments in a timely manner – six major amendments managed during trial implementation Improved capacity of committee members to provide ethical oversight for future clinical trials of similar complexity
NTP/NTRL	Activities: Site provided continuous trial updates, including trial participants’ treatment experience, adherence and retention to stakeholders through in person meetings and updates in the Mongolian Journal of Infectious Research Diseases (MJIRD) Site team regularly provided training to NTP/NTRL staff covering basics of clinical trials, Good Laboratory and Pharmacy Practices, and community engagement experiences. Trial’s central laboratory in Belgium trained NTRL on trial-specific methods and assessments, as well as introduction of new methods, such as fluorescein diacetate for vital staining for detecting viability of acid-fast bacilli Strategic insights: Knowledge dissemination and capacity building were key to reciprocal relationships with the NTP and resulted in both immediate (weekly group email from the NTP on newly registered DR-TB patients that facilitated timely referral, screening and enrolment of trial participants) and long-term (invitation to support development of national plans, guidelines, funding proposals) positive outcomes.	Timing: Commencing approx. one month before Site Initiation and continuing throughout implementation Mode: In-person/email/publication Frequency: As needed Written materials used (if any): updates in the Mongolian Journal of Infectious Research Diseases (MJIRD); Site team leveraged the MJIRD News section to enhance trial transparency and stakeholder engagement by publishing several articles. These covered trial implementation, clinical, lab, pharmacy-specific aspects, and key updates, ensuring informed participation and reinforcing the trial’s credibility within the research and healthcare community.	Financial and human capacity constraints Operational barriers Competing demands	Close collaboration between trial team and NTP/NTRL resulted in (i) high referrals/recruitment; (ii) higher retention rate and (iii) improved data quality because of higher efficiency in managing trial procedures, and therefore better adherence to trial protocol. Importantly, successful engagement of these stakeholders resulted in high level buy-in for the trial, and contributions to programmatic planning and policymaking. NTRL capacitated by trial’s central laboratory on new laboratory methods
Frontline health workers	Activities: Site provided training and online support to health workers from family health centers and TB dispensaries and defined a model for collaboration with frontline health facilities. Strategic insights: Continuous engagement between clinical teams of the site and frontline health facilities ensured prompt resolution of queries that prevented delays or missed opportunities for enrolment, and reduced errors in patient follow-up management.	Timing: Two months after the Site initiation and continued monthly Mode: In-person Frequency: The site team conducted an initial meeting with district TB dispensary staff, followed by quarterly face-to-face supportive supervision. Written materials used (if any): Introductory slides outlining the trial and detailed implementation activities; trial treatment cards; and drug and injection logs (injection log was used during Stage 1 of the trial)	Financial and human capacity constraints Lack of favorable research environment Operational barriers Competing demands	Improved implementation efficiency by ensuring high recruitment/retention rates; and enhanced quality by ensuring adherence to treatment and follow-up. Contributed to sustainable strengthening of human resource capacity by equipping frontline health workers with trial experience that can be useful for future trials in Mongolia.
CSOs	Activities: Site formed a TB CAB comprising CSOs, reps from affected communities, trial participants, and staff with defined roles in specific areas of trial implementation: • Treatment management and adherence (DOT) support • Ongoing participant support through routine phone calls and periodic home visits, especially enhanced during the COVID-19 pandemic • Evaluation and refining of community engagement strategies. Strategic insights: Trial implementation that was inclusive of the CSOs/CAB was sensitive to participant needs and allowed for adherence to treatment and follow-up visits, and supportive home visits for care. Further, equipping CSOs with knowledge enhanced transparency and increased buy-in from the community for trial conduct.	Timing: Six months after the Site initiation of Stage 1 and continued during the Stage 2 trial implementation Mode: In-person/emails Frequency: An initial three-day meeting with the CSOs, followed by quarterly meetings and an annual general CAB meeting with all stakeholders. Written materials used (if any): Introductory slides outlining the trial and its implementation activities; trial progress presentations including CAB support for participants, as well as challenges and successes; and summary of CAB outreach efforts.	Lack of favorable research environment Operational barriers Competing demands	High retention rate for the trial, facilitated by CAB members’ support to patients and adjustments made by site team in response to participant feedback re: safety and well being Low loss to follow up/high adherence rate for the trial facilitated by CAB members’ support to patients Integration of CAB experiences (home and video DOT, joint patient and family member meetings) into the operations of the TB district dispensary Development of a model for community engagement/collaboration between trial teams and CSOs that can be used for future TB trials
People affected by MDR-TB	Activities: Site and CAB organized joint meetings between trial participants/their families, and trial staff to share ongoing updates, explain trial procedures and clarify support available to them. Site also facilitated engagement with people affected by MDR-TB by ensuring their representation in and contribution to the CAB. Strategic insights: Engaging trial participants, their families, and other people affected by MDR-TB was critical to fostering respect and transparency.	Timing: Four months after the SIV, engagement continued in alignment with trial enrollment to include newly enrolled patients and their families Mode: In-person Frequency: As needed Monthly food support and visit reminders. 26 joint meetings in total with trial participants/families. Written materials used (if any): N/A	Lack of favorable research environment Operational barriers	High recruitment/retention rates and increased buy-in for the trial facilitated by improved patient experience. Enhanced understanding, and reduced stigma of TB within communities. Development of a successful model for community engagement and collaboration.
Wider Community	Activities: Site and CAB participated in Television Health Programs to share information on STREAM, to increase awareness of TB and the trial, and to advocate for TB affected communities and key vulnerable populations CAB conducted outreach activities at a secondary school and in five khoroosλ across three districts of Ulaanbaatar, directly engaging with 400 people and enhancing local awareness of TB. Strategic insights: Diverse media engagement and ongoing community outreach to increase awareness of TB across multiple strata proved helpful to increasing acceptance of research and uptake of findings.	Timing: Following the availability of both the preliminary and the final results Mode: In-person/Media channels Frequency: As needed Five TB-related health and news channels segments and featured in radio news twice. Written materials used (if any): Trial information pamphlets and a trial summary page.	Lack of favorable research environment Operational barriers	Enhanced understanding and reduced stigma of TB in the community Higher acceptance of TB research

^λsymbol specifies the smallest administrative unit under the provinces